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4.3.2011 Official
Journal
of
the
European
Union L
59/71
COMMISSION DECISION
of 3 March 2011
concerning the non-inclusion of ethoxyquin in Annex I to Council Directive 91/414/EEC and
amending Commission Decision 2008/941/EC
(notified under document C(2011) 1265)
(Text with EEA relevance)
(2011/143/EU)
THE EUROPEAN COMMISSION,
(4) The
application
was
submitted
to
Germany,
which
had
been designated rapporteur Member State by Regulation
(EC) No 2229/2004. The time period for the accelerated
Having regard to the Treaty on the Functioning of the European
procedure was respected. The specification of the active
Union,
substance and the supported uses are the same as were
the subject of Decision 2008/941/EC. That application
also complies with the remaining substantive and
Having regard to Council Directive 91/414/EEC of 15 July
procedural requirements of Article 15 of Regulation
1991 concerning the placing of plant protection products on
(EC) No 33/2008.
the market ( 1 ), and in particular the fourth subparagraph of
Article 8(2) thereof,
(5) Germany
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
Whereas:
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 16 October 2009. The Authority
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
communicated the additional report to the other
No 2229/2004 ( 3 ) lay down the detailed rules for the
Member States and the applicant for comments and
implementation of the fourth stage of the programme
forwarded the comments it had received to the
of work referred to in Article 8(2) of Directive
Commission. In accordance with Article 20(1) of Regu
91/414/EEC and establish a list of active substances to
lation (EC) No 33/2008 and at the request of the
be assessed, with a view to their possible inclusion in
Commission, the Authority presented its conclusion on
Annex I to Directive 91/414/EEC. That list included
ethoxyquin to the Commission on 20 August 2010 ( 6 ).
ethoxyquin.
The draft assessment report, the additional report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
No
Standing Committee on the Food Chain and Animal
2229/2004 the notifier withdrew its support of the
Health and finalised on 28 January 2011 in the format
inclusion of that active substance in Annex I to
of the Commission review report for ethoxyquin.
Directive 91/414/EEC within 2 months from receipt of
the draft assessment report. Consequently, Commission
Decision 2008/941/EC of 8 December 2008 concerning
(6) During
the
evaluation
of
this
active
substance,
a
number
the non-inclusion of certain active substances in Annex I
of concerns have been identified. In particular, it was not
to Council Directive 91/414/EEC and the withdrawal of
possible to perform a reliable consumer, operator and
authorisations for plant protection products containing
worker exposure assessment, due to the limited toxico
these substances ( 4 ) on the non-inclusion of ethoxyquin
logical data package, considered insufficient to set the
was adopted.
Acceptable Daily Intake (ADI), the Acute Reference
Dose (ARfD) and the Acceptable Operator Exposure
Level (AOEL). Furthermore, the data submitted were
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
insufficient to set a residue definition for ethoxyquin
original notifier (hereinafter ‘the applicant’) submitted a
and its metabolites. In addition, data were missing to
new application requesting the accelerated procedure to
conclude on the genotoxic potential and the ecotoxicity
be applied, as provided for in Articles 14 to 19 of
of an impurity in the technical specifications, for confi
Commission Regulation (EC) No 33/2008 of
dentiality reasons referred to as impurity 7. Finally, the
17 January 2008 laying down detailed rules for the
data available were not sufficient to fully assess the risks
application of Council Directive 91/414/EEC as regards
to the environment and to non-target organisms.
a regular and an accelerated procedure for the assessment
Consequently, it was not possible to conclude on the
of active substances which were part of the programme
basis of the information available that ethoxyquin met
of work referred to in Article 8(2) of that Directive but
the criteria for inclusion in Annex I to Directive
have not been included into its Annex I ( 5 ).
91/414/EEC.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review
( 2 ) OJ L 168, 27.6.2002, p. 14.
of the pesticide risk assessment of the active substance
( 3 ) OJ L 379, 24.12.2004, p. 13.
ethoxyquin. EFSA Journal 2010;8(9):1710. [38 pp.]. doi:10.2903/
( 4 ) OJ L 335, 13.12.2008, p. 91.
j.efsa.2010.1710. Available online: www.efsa.europa.eu/efsajournal.
( 5 ) OJ L 15, 18.1.2008, p. 5.
htm

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L 59/72
EN
Official Journal of the European Union
4.3.2011
(7) The
Commission
invited
the
applicant
to
submit
its HAS ADOPTED THIS DECISION:
comments on the results of the peer review. Furthermore,
in accordance with Article 21(1) of Regulation (EC) No
Article 1
33/2008, the Commission invited the applicant to
Ethoxyquin shall not be included as active substance in Annex I
submit comments on the draft review report. The
to Directive 91/414/EEC.
applicant submitted its comments, which have been
carefully examined.
Article 2
Member States shall ensure that:
(8) However,
despite
the
arguments
put
forward
by
the
applicant, the concerns identified could not be elim
(a) authorisations for plant protection products containing
inated, and assessments made on the basis of the
ethoxyquin are withdrawn by 3 September 2011;
information submitted and evaluated during the
Authority expert meetings have not demonstrated that
(b) no authorisations for plant protection products containing
it may be expected that, under the proposed conditions
ethoxyquin are granted or renewed from the date of publi
of use, plant protection products containing ethoxyquin
cation of this Decision.
satisfy in general the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC.
Article 3
Any period of grace granted by Member States in accordance
(9) Ethoxyquin
should
therefore
not
be
included
in
Annex
I with the provisions of Article 4(6) of Directive 91/414/EEC,
to Directive 91/414/EEC.
shall be as short as possible and shall expire on 3 September
2012 at the latest.
(10) This
Decision
does
not
prejudice
the
submission
of
a
Article 4
further application for ethoxyquin pursuant to
Article 6(2) of Directive 91/414/EEC and Chapter II of
In the Annex to Decision 2008/941/EC, the entry for
Regulation (EC) No 33/2008.
‘ethoxyquin’ is deleted.

Article 5
(11) In
the
interest
of
clarity,
the
entry
for
ethoxyquin
in
the
This Decision is addressed to the Member States.
Annex to Decision 2008/941/EC should be deleted.
(12) It is therefore appropriate to amend Decision
Done at Brussels, 3 March 2011.
2008/941/EC accordingly.
For the Commission
(13) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
John DALLI
Committee on the Food Chain and Animal Health,
Member of the Commission

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